Published on 26 September 2022

Around a quarter of people with diabetes experience neuropathy that can seriously disrupt day-to-day activities.

The largest study of its kind to date has offered hope for improved quality of life for people living with diabetes-related neuropathy.

Researchers at Sheffield Teaching Hospitals NHS Foundation Trust said that diabetes patients experiencing neuropathic pain could benefit as a result of findings from the largest and longest ever neuropathic pain trial in the world.

Diabetes-related peripheral neuropathic pain (DPNP) is caused by a type of nerve damage which may result in severe pain in the feet, legs and hands.

Neuropathic pain, often described as a burning or electric shock-like sensation, can be debilitating for people with condition.

Affecting up to a quarter of people with diabetes, neuropathy can cause severe disruption to daily activities and may lead to depression, anxiety, lack of sleep and a poor quality of life.

A healthcare professional checking someone's foot.

The OPTION-DM trial, funded by the National Institute for Health Research (NIHR), followed 130 patients across 13 centres in the UK for a 51-week period.

Findings from the study, recently published in The Lancet, will inform future treatment guidelines, not only for neuropathic pain in diabetes patients, but chronic neuropathic pain treatment in general.

Current guidance from the National Institute for Health and Care Excellence (NICE) recommends a choice of amitriptyline, duloxetine, pregabalin and gabapentin as initial treatment for DPNP, however until now there has been little comparative evidence on which is best, or whether they should be combined. The OPTION-DM trial investigated all but gabapentin (which works similarly as pregabalin) and their combinations.

Researchers sought to understand which medication treatment choices work best for patients and whether combination drugs are more effective than single medications at a maximum dose.

Findings from the trial have demonstrated that all treatments provided similar and significant pain reduction for patients.

The trial also found that combination treatment, where needed, led to significantly better pain relief and improved quality of life for patients.

Neuropathy team photo.

Picture: Professor Solomon Tesfaye (middle left) with members of the OPTION-DM trial team at Sheffield Teaching Hospitals NHS Foundation Trust

Professor Solomon Tesfaye, Research Director of Diabetes and Endocrinology, and Consultant Physician/Endocrinologist at Sheffield Teaching Hospitals NHS Foundation Trust, who led the study, said: “This trial brings focus on the plight of people who suffer from painful neuropathy and will lead to increased awareness and improved treatment for patients. Despite large variations in the cost and availability of each medication, it is reassuring that amitriptyline, duloxetine and pregabalin, and their combinations are similar in their effectiveness for relieving pain and so this study has great potential to influence treatment guidelines for DPNP, not only in the UK, but across the world. I would like to thank all the patients who participated in this long and demanding trial.”

The results from the OPTION-DM trial will be instrumental in improving treatment and quality of life for patients suffering with DPNP.

The report said: “To our knowledge, this was the largest and longest ever, head-to-head, crossover neuropathic pain trial. We showed that all three monotherapies and their combinations had similar analgesic efficacy. Combination treatment was well tolerated and led to improved pain relief in patients with suboptimal pain control with a monotherapy.”

Read the report in The Lancet
Read the DRWF information leaflet How can diabetes affect my feet?
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